Internationally Accredited Testing & Certification
Organization



Certification Programs
2010


The Glycemic Research Institute® is an Internationally Accredited Testing & Certification Organization approved by International Governments, including the United States government.

The Glycemic Research Institute® Certification Program and Certification Programs are Registered, Authorized, and Licensed by the United States, Canada, and United Kingdom governments, and accepted Worldwide per World Health Organization (WHO) Guidelines.

The Glycemic Research Institute® government-issued Certification Marks represent 25-years of Clinical Research in the fields of the Glycemic Index, Diabetes, Cephalic Response, Obesity, Adipose Tissue Fat-Storage, and Childhood Obesity.

The Glycemic Research Institute® Certification Marks are legally authorized to make a clinical statement, such as “LOW GLYCEMIC” or ‘DIABETIC FRIENDLY” or “LOW CEPHALIC INDEX” or “KID FRIENDLY” or “NATURAL BEVERAGE” on an FDA label for a commercial food, Nutraceutical, beverage, or Pharmaceutical product.

Any Certification Mark statement representing a clinical claim must be backed by Human In Vivo Clinical Trials per FDA CFR 21 guidelines and per the Clinical Trials Guidelines submitted by the organization licensed to use said Certification Mark.

A Certification Mark on a commercial product legally enables bounding (being under legal obligation) under the following guidelines:


The existence of a Legal Product Certification Agreement between the manufacturer of a product and the organization that possesses accreditation by a national government for both testing and product certification.
Legal evidence that the product was successfully tested in accordance with a nationally accredited standards.
Legal assurance the accredited certification organization has ensured that the item that was successfully tested, and is identical to that which is being offered for sale.
Legal assurance that the successful test has resulted in a certification listing, which is considered public information, which sets out the tolerances and conditions of use for the certified product, to enable bounding, and thus compliance with the law.
Legal assurance that the manufacturer is being regularly audited by the Certification Organization, at unannounced intervals, to ensure the maintenance of the original process standard that was employed in the manufacture of the test specimen that passed the test, and that if the manufacturer should fail an audit, all product certification, including labels of stock on hand, on construction sites, with end-user customers and on distributor store shelves, shall be immediately removed, and all stakeholders will be informed that the de-listed product certification is no longer eligible for use in bounding.


Quality Assurance
The Legal Relationship Between Certifier & Client


Product certification and product qualification is the cornerstone of all bounding for Certification Marks, and the process of certifying that a specific product has passed performance and quality assurance tests or qualification requirements stipulated in regulations and Nationally Accredited Test Standards, and that a product complies with a set of regulations governing quality and/or minimum performance requirements.

On the part of the certifier, in this case, the Glycemic Research Institute® (GRI), is certifying that a product has passed all Clinical Protocols established to use the Glycemic Research Institute® Certification Marks on a label and/or product marketing materials, including websites.

For products that pass the strict Clinical Protocol, the Glycemic Research Institute® allows the use the GRI Mark on the product label, thus indicating legal eligibility of the product for use in bounding, and certifies the origin, material, mode of manufacture of products, mode of performance of services, quality, and accuracy of other characteristics of the product.

Products, once certified, may be endorsed with the Authorized Certification Mark and may be eligible to display said Certification Mark, under the direction and guidelines of the Glycemic Research Institute®.



Trademarks vs
Certification Marks


Trademarks are vastly different from Certification Marks. Trademarks are issued to individuals and companies and represent a word (s) or logo used by that entity.

Certification Marks are difficult to register, and are only issued by the government to companies that are Nationally Accredited Testing and Certification Organizations.

It is difficult, lengthy, and expensive to obtain a Certification Mark from the government, as the organization applying for said Mark must prove worthiness on many different levels of competence, expertise, and good standing in the community.

Companies that are legally issued a Certification Mark must follow strict government guidelines in order to obtain, maintain and continue to use said Marks.



Example of Valid
Certification Marks


The main purpose of government Certification Mark regulations is to protect consumers against misleading practices.

Some of the more commonly seen Certification Marks are:


Underwriters Laboratories holds a service mark on the phrase "UL Listed," and allows manufacturers of electrical and other safety equipment to use the UL mark only if they are under follow-up agreement by UL. This lets consumers identify products that meet quality criteria set by a company other than the manufacturer.
 
The "Champagne" certification mark, used to indicate goods which have an appellation of origin of the Champagne region in France.
The Bureau Veritas Certification Mark, used to indicate the Sea-Worthiness of Ships.
(U in a full circle), the hechsher of the Orthodox Union.
Underwriters' Laboratories of Canada (ULC), is an affiliate of Underwriters Laboratories. ULC is accredited in Canada to conduct testing and to provide certification, and to author National Standards.


Legal Requirements for
Certification Marks


Authorized Certification Mark issuers are required and must observe the construction of test specimens to avoid any possible cheating on the part of the submitter or parties affiliated with the submitter.

This is mandated to avoid having an unethical submitter attempt to have certified, a product that is not identical to the original product submitted.

As a result of documented abuses in this field, certifiers typically reserve the right to re-test as a cautionary measure to ward off such behavior.



De-Listing


De-Listing is the process of recalling a Certification for a specific product. While De-Listing is rare, it has occurred, which has resulted in having strict and mandatory Certification regimes in place.

De-Listing can occur as a result of inaccurate data provided by the client deliberately or non-deliberately submitting a product (such as incorrect Ingredient Listings or Label data), or from Incremental Degradation of a product (changing the original product formula/ingredients from the original), or using the Certification Mark in an illegal and/or unauthorized manner.

The Glycemic Research Institute® holds full authority to De-List and Recall its government Certification Marks as a result of any breach of protocol on behalf of a client and/or product submitted.

Said breaches include using the Certification Mark on a product that has passed the Glycemic Research Institute® Clinical Trial Protocol, wherein said product has been sub-licensed to another company. In said case, the Mark cannot be utilized by the sub-licensee without the product being re-submitted to Glycemic Research Institute® for Clinical Trials.

Only "active" Certification Mark listings matter at the point of purchase or use, as products and companies can become "De-Listed" as a result of improprieties.

The active Certification Mark listing is the cornerstone of all bounding in actual use. It is a legal document against which the product is compared to approvals by an Authority Having Jurisdiction (AHJ).



Active Certification

|
An Active Certification listing indicates three mandates:

The product is being made under a Certification, or follow-up agreement that exists between the manufacturer and the certification organization. This means that the certifier can conduct up to 4 unannounced factory audits per year, for the purpose of ensuring that the product being made and sold is still identical to that which was tested.
The product's packaging, literature and the manufacturer's promotional information is authorized to use the Certification Mark.
The listing is held and is listed in the Certification Listings Directory of the Certification Organization.

Certification Marks are very highly regarded by governments Worldwide, as well as by stockholders and investors of high-quality products. Accredited Testing Organizations, such as the Glycemic Research Institute®, are relied on to provide accurate and legal reports and data regarding specific products.

In Germany, Accredited Testing Organizations routinely audits manufacturing locations and submits quality control results to the government and to investors and stockholders.

De-Listing can occur in the case of non-compliance. Trends in quality are identified very early and brought to the attention of all stakeholders to enable the prevention of problems.



Presentation of Active
Certification Marks


Certification Marks are easy to see on product labels and enable users to track down the Certification Listings, the tolerances that guide field use, and whether or not the listing is still active.

In certain cases, a Certification Mark can mean the difference between life-and-death. As an example, fire extinguishers, fire alarms, electrical equipment, hospital equipment, emergency room equipment, Paramedic equipment, and surgery-room equipment, must be clearly labeled with appropriate Certifications.

This understates the reasoning for utilizing and maintaining appropriate Certifications, and personifies the illegality of obscuring a Certification label.

The Glycemic Research Institute® requires the use of its Certification Marks to be presented clearly on the front of a food, beverage, Nutraceutical, or Pharmaceutical label.



Human Clinical Trials
are Required for
"Low Glycemic"
Substantiation


2010: Government requirements related to any “Glycemic” claim, such as “Low Glycemic” require mandatory Human In Vivo Clinical Trials.

All carbohydrates mediate different glycemic properties depending on the food matrix, and no predictions can be made or legally asserted without proof of Human In Vivo Clinical Trials.

Additionally, all foods and beverages produced without carbohydrates or calories or sugars, such as "Calorie-Free, No Sugars or Carbs" elicit a Cephalic Response, also called Brain Glycemic Indexing, which can be quantified in an approved Cephalic Testing laboratory.


The Glycemic Research Institute® Official Trials Laboratory (Glycemic Research Laboratories) is the only Certified Cephalic Testing Laboratory in the world (United States Government Certification Program).
www.GlycemicResearchLaboratories.com


Glycemic claims related to an analysis or mathematical analysis or composition of the product ingredients or any methodology other than Human In Vivo Clinical Trials are not legal.

Dr. Jeya Henry, professor of human nutrition at Oxford Brookes University, a leading authority on diet and glycaemic (glycemic) response, states:

“It is right to be cautious as it is not possible to ascribe a Glycemic Index rating to a food by analysis in a lab or predictions based on its composition; testing must be done on humans.

The United States government (FDA) (FTC) mandates that Human Clinical Trials are required for any “Glycemic” claim or statement, per 21 CFR Guidelines.

The Canadian government also mandates Human In Vivo Clinical Trials for any “Glycemic” claims.

The governing body in the United Kingdom (UK), the European Food Safety Authority (EFSA), 2010 ‘article 13.1’ mandates strict control over any food or beverage making “Glycemic” claims. The EFSA accepts that there is merit in trying to control blood glucose, but requires convincing evidence including Human In Vivo Clinical Trials submitted for claims.

The Glycemic Research Institute® Clinical Trials Program for Glycemic Claim Substantiation is Registered by the United Kingdom government, the United States government, and the Canadian government.


Submitting a Product to
the Glycemic Research
Institute®

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Product Application Documents

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